The importance of a robust human factors engineering program in medical product development, particularly combination products

Liz Mauer, Senior Technical Director; Rachel Aronchick, Technical Director; Eurofins Human Factors MD

In early September, the FDA’s Office of Combination Products finalized the guidance document, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development with a helpful Q&A document: Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.

We at Eurofins Human Factors MD were glad to see that the FDA continues to emphasize the importance of a robust human factors engineering program in medical product development, particularly when it comes to combination products. Our key takeaway? A robust HFE program is clearly critical and not just a “nice to have.”

Throughout the Q&A document, the existing 2016 final guidance (published by CDRH), Applying Human Factors and Usability Engineering to Medical Devices, was referenced several times and still serves as an important reference for combination product development. However, because unique aspects of combination products warrant nuanced considerations, the new Q&A guidance document offered clarity on a couple of valuable points for manufacturers:

• Consider the combination product as parts, in addition to as a whole. Combination products are comprised of two or more different types of products (i.e., a combination of a drug, device, and/or biological product with one another). As such, in the context of human factors, there may be use-related risks associated with the device only, use-related risks associated with the drug only, or use-related risks associated with the combination product that do not exist in the individual components. Therefore, it’s important to consider the entire user interface, rather than considering the device and drug in a “siloed” manner, to ensure a thorough understanding of how the final finished combination product could affect users’ interactions.
• Develop a Use-Related Risk Analysis (URRA) that stands alone. Attempting to incorporate use-related use issues in traditional engineering risk analysis (e.g., dFMEA, pFMEA, etc.) is not an appropriate approach given the expectations of the respective analyses. Ensure that the URRA exists separately from the full engineering risk analysis and focuses on use-related risks that could lead to harm or compromised medical care.
• Identify meaningful critical tasks. The document provides some clear examples of what would be considered non-critical vs. critical when it comes to identifying critical tasks. In general, if a use issue impacts dosing, administration, or could lead to actual harm (such as physical injury, adverse events, events that may need patient monitoring to confirm no harm, or events that may lead to hospitalization), it would be considered critical. However, if there is no urgency associated with task completion, if the issue is not likely to be repeated, or if the use issue is not linked to physical injury, it’s unlikely that the task would be considered critical.
• Consider your training approach and replicate it in your HF Validation study. Participant training (or lack thereof) during an HF validation test has been a hot topic for years. The guidance comes closer to providing some clear expectations, but still leaves some room for considering training approaches on a case-by-case basis. In summary:
  • If training is part of your UI design requirements, validate your training during the HF validation test.
  • If training is not part of your UI design requirements, do not include training in the HF validation test.
  • If training is optional, may occur during actual use, or cannot be guaranteed upon commercialization, then the HF validation test may include both trained and untrained users. However, it seems there are still some instances where it may be acceptable to include only untrained users to assess a “highest risk scenario.”

Of course, each combination product may have unique attributes that warrant special consideration. As such, we always recommend pre-submitting an HF validation protocol to the FDA for a pre-submission review to help de-risk the ultimate marketing submission.

If you have questions about how to apply this guidance to your product, CONTACT US to see how we can help.